7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
JMS APHERESIS NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CALYPSO 4D LOCALIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Savion DLVR Guidewire, Savion FLX Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVOSYN VIOLET 2 (5) 4X4CM HR 48TO (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·May 28, 2014
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025